Multicenter phase 2 trial of camrelizumab plus apatinib in advanced urachal cancer

Urachal carcinoma (UrC) is a rare adenocarcinoma for which no standard treatment exists. The Chinese multicenter phase 2 RUN-SC-0102 evaluates treatment for patients with rare cancer types. The results of the UrC cohort have now been published. The cohort enrolled 20 patients from two centers (Shanghai and Beijing) with histologically confirmed UrC who were refractory to at least one line of systemic chemotherapy and had no prior exposure to PD-1/PD-L1 or VEGF-targeted agents. The patients received camrelizumab (200 mg intravenously, once every 3 weeks) plus apatinib (250 mg oral, once daily). The primary endpoint was objective response rate. The objective response rate was 40% (95% CI 19.8-63.1) and the clinical benefit rate was 50% (27.2-72.8), with median duration of response 7.5 months (7.0-NR) and median progression-free survival 5.5 months (3-NR). The disease control rate was 95% (95% CI 79.2-99.2), comprising 8 partial responses dan 11 stable diseases as best overall response. With a median follow-up duration of 13.6 months, median overall survival was not reached. Nine patients (45%) experienced grade 3 and 4 adverse events; no grade 5 toxicities were observed. The authors conclude that combined PD-1 and VEGFR inhibitor therapy for advanced UrC was well tolerated and clinically active.